Compliance/Governance (for Edinburgh)
RSpace uses HTTPS to encrypt network connections, and passwords are stored securely. Compliance with the US Food and Drug Administration’s Title 21 CFR part 11 (21CFR11) is the international standard for scientific data management, and RSpace is no exception. The key elements of 21CFR11 that are supported by RSpace are as follows:
- Data is true and accurate record of your work.
- Ability to create accurate copies and human readable exports for inspection.
- Limited, secure, role-based access by authorized individuals only.
- Secure audit trail that records all user actions with computer generated timestamps.
- All changes are visible, older versions remain available for inspection.
- All records remain available in the system for the period of the study (i.e. permanently for most academic labs).
- Training in proper use of the system is available and completed by all users.
- Digital signatures can be used to lock documents and signatures cannot be separated from the data they safeguard.
- Proper password management procedures, system security and access / activity logging are all part of the system.
- For the highest level of compliance, your lab procedures will need to be professionally validated in-situ by qualified specialists. The team at ResearchSpace can assist you with every step of this process.